NCT01391988

Brief Summary

Prospective trial comparing post-operative complications and seroma formation after mastectomy in patients with breast cancer, using conventional electric scalpel and harmonic scalpel.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2011

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 12, 2011

Completed
Last Updated

March 7, 2014

Status Verified

March 1, 2014

Enrollment Period

10 months

First QC Date

June 24, 2011

Last Update Submit

March 6, 2014

Conditions

Complication, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Differences in operative conditions and first week seroma drainage

    Time of the surgery and blood loss volume during surgery. Drain volume postoperative in the first week

    1 week.

Secondary Outcomes (1)

  • Differences in local complication

    day 7 and day 14

Study Arms (2)

Electric Scalpel Mastectomy

ACTIVE COMPARATOR

Radical mastectomy with electric scalpel

Procedure: Electric scalpel

Harmonic scalpel mastectomy

EXPERIMENTAL

Radical Mastectomy with harmonic scalpel

Procedure: Harmonic scalpel

Interventions

Electric scalpelPROCEDURE

Radical mastectomy with electric scalpel. Electric scalpels were calibrated at 40 watts of cutting and coagulation power.

Electric Scalpel Mastectomy
Harmonic scalpelPROCEDURE

Radical mastectomy with harmonic scalpel. Harmonic GEN04 generator calibrated at power leve 3 and 5, using the HP054 handpiece and HF 105 curved blade

Harmonic scalpel mastectomy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Breast carcinoma (ductal or lobular)
  • Modified radical mastectomy was the surgery to be realized

You may not qualify if:

  • Blood dyscrasia, collagen diseases, known uncontrolled chronic diseases, infections (mammary or axillary), ulcerated tumors and pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Câncer de Barretos.

Barretos, São Paulo, 14.784.400, Brazil

Location

Related Publications (9)

  • Lumachi F, Brandes AA, Burelli P, Basso SM, Iacobone M, Ermani M. Seroma prevention following axillary dissection in patients with breast cancer by using ultrasound scissors: a prospective clinical study. Eur J Surg Oncol. 2004 Jun;30(5):526-30. doi: 10.1016/j.ejso.2004.03.003.

    PMID: 15135481BACKGROUND

  • Lumachi F, Burelli P, Basso SM, Iacobone M, Ermani M. Usefulness of ultrasound scissors in reducing serous drainage after axillary dissection for breast cancer: a prospective randomized clinical study. Am Surg. 2004 Jan;70(1):80-4.

    PMID: 14964555BACKGROUND

  • Kozomara D, Galic G, Brekalo Z, Sutalo N, Kvesic A, Soljic M. A randomised two-way comparison of mastectomy performed using harmonic scalpel or monopolar diathermy. Coll Antropol. 2010 Mar;34 Suppl 1:105-12.

    PMID: 20402305BACKGROUND

  • Kurtz SB, Frost DB. A comparison of two surgical techniques for performing mastectomy. Eur J Surg Oncol. 1995 Apr;21(2):143-5. doi: 10.1016/s0748-7983(95)90171-x.

    PMID: 7720886BACKGROUND

  • Deo SV, Shukla NK, Asthana S, Niranjan B, Srinivas G. A comparative study of modified radical mastectomy using harmonic scalpel and electrocautery. Singapore Med J. 2002 May;43(5):226-8.

    PMID: 12188072BACKGROUND

  • Galatius H, Okholm M, Hoffmann J. Mastectomy using ultrasonic dissection: effect on seroma formation. Breast. 2003 Oct;12(5):338-41. doi: 10.1016/s0960-9776(03)00110-3.

    PMID: 14659149BACKGROUND

  • Adwani A, Ebbs SR. Ultracision reduces acute blood loss but not seroma formation after mastectomy and axillary dissection: a pilot study. Int J Clin Pract. 2006 May;60(5):562-4. doi: 10.1111/j.1742-1241.2006.00689.x.

    PMID: 16700855BACKGROUND

  • Miller E, Paull DE, Morrissey K, Cortese A, Nowak E. Scalpel versus electrocautery in modified radical mastectomy. Am Surg. 1988 May;54(5):284-6.

    PMID: 3364865BACKGROUND

  • Ribeiro GH, Kerr LM, Haikel RL, Peres SV, Matthes AG, Depieri Michelli RA, Bailao A Jr, Fregnani JH, Vieira RA. Modified radical mastectomy: a pilot clinical trial comparing the use of conventional electric scalpel and harmonic scalpel. Int J Surg. 2013;11(6):496-500. doi: 10.1016/j.ijsu.2013.03.013. Epub 2013 Apr 8.

    PMID: 23579255DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Edmundo C Mauad, MD, PhD

    Director from Barretos Cancer Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2011

First Posted

July 12, 2011

Study Start

January 1, 2008

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

March 7, 2014

Record last verified: 2014-03

Locations

BR(1)